Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery
NCT ID: NCT00392184
Last Updated: 2015-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
274 participants
INTERVENTIONAL
2000-11-30
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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APBI
Accelerated Partial Breast Irradiation with interstitial Brachytherapy
Accelerated partial breast irradiation
Interventions
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Accelerated partial breast irradiation
Eligibility Criteria
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Inclusion Criteria
* pN0 or pN1 mi
* M0 and no contralateral BC
* Clear margins (≥ 2 mm)
* Age ≥ 35 years
* ER and/or PR positive
Exclusion Criteria
* EIC
* Lymphovascular invasion
* Poorly differentiated tumors
* Diffuse microcalcifications
35 Years
80 Years
FEMALE
No
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Principal Investigators
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Vratislav Strnad, MD
Role: STUDY_CHAIR
University Hospital Erlangen, Germany
Oliver J Ott, MD
Role: STUDY_DIRECTOR
University Hospital Erlangen, Germany
Guido Hildebrandt, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Leipzig, Germany
Richard Pötter, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital AKH Vienna, Austria
Joe Hammer, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Barmherzige Schwestern Linz, Austria
Locations
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Hospital Barmherzige Schwestern Linz
Linz, , Austria
University Hospital AKH Vienna
Vienna, , Austria
University Hospital Erlangen
Erlangen, , Germany
University Hospital Leipzig
Leipzig, , Germany
Countries
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References
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Ott OJ, Potter R, Hammer J, Hildebrandt G, Lotter M, Resch A, Pohls U, Beckmann MW, Sauer R, Strnad V. Accelerated partial breast irradiation with iridium-192 multicatheter PDR/HDR brachytherapy. Preliminary results of the German-Austrian multicenter trial. Strahlenther Onkol. 2004 Oct;180(10):642-9. doi: 10.1007/s00066-004-1294-2.
Strnad V, Ott O, Potter R, Hildebrandt G, Hammer J, Resch A, Lotter M, Ackermann S, Beckmann MW, Sauer R. Interstitial brachytherapy alone after breast conserving surgery: interim results of a German-Austrian multicenter phase II trial. Brachytherapy. 2004;3(3):115-9. doi: 10.1016/j.brachy.2004.08.003.
Ott OJ, Potter R, Hildebrandt G, Hammer J, Lotter M, Beckmann MW, Sauer R, Strnad V. [Partial breast irradiation for early breast cancer with favorable prognostic factors: 3-year results of the German-Austrian phase II-trial]. Rofo. 2005 Jul;177(7):962-7. doi: 10.1055/s-2005-858268. German.
Ott OJ, Hildebrandt G, Potter R, Hammer J, Hindemith M, Resch A, Spiegl K, Lotter M, Uter W, Kortmann RD, Schrauder M, Beckmann MW, Fietkau R, Strnad V. Accelerated partial breast irradiation with interstitial implants: risk factors associated with increased local recurrence. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1458-63. doi: 10.1016/j.ijrobp.2010.04.032. Epub 2010 Aug 2.
Other Identifiers
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German-Austrian APBI Trial
Identifier Type: -
Identifier Source: org_study_id
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